UMIN-CTR Clinical Trial

Basic information
Public title	Effect of the test food consumption on Saliva Production: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study
Acronym	Effect of the test food consumption on Saliva Production: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study
Scientific Title	Effect of the test food consumption on Saliva Production: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study
Scientific Title:Acronym	Effect of the test food consumption on Saliva Production: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the increase in saliva production by ingesting the test food.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Amount of change in saliva secretion after two weeks of start intake of the test food from screening test.
Key secondary outcomes	1. Amount of change in saliva secretion after one week of start intake of the test food from screening test. 2. Measured amount of saliva secretion after one week of start intake of the test food. 3. Measured amount of saliva secretion after two weeks of start intake of the test food.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Period I: Active hard capsule Period II: Placebo Administration: <Period I, Period II>Take 1 capsule once a day after breakfast. *The intervention sequence is Period I to Period II, and each food is single ingestion.
Interventions/Control_2	Period I: Placebo Period II: Active hard capsule Administration: <Period I, Period II>Take 1 capsule once a day after breakfast. *The intervention sequence is Period I to Period II, and each food is single ingestion.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. In-house employees 2. Healthy subjects who lack the moisture of the mouth 3. Subjects with low saliva volume at screening
Key exclusion criteria	1. Subjects with low saliva production at screening test (< 2 g by Saxon test) 2. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction. 3. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD). 4. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases. 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily. 6. Subjects who are currently taking medications (including herbal medicines) and supplements. 7. Subjects who are allergic to medicines and/or the test food related products. 8. Subjects who are pregnant, lactation, or planning to become pregnant. 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period. 10. Subjects who have history of respiratory disease or current illness. 11. Subjects with autoimmune disease. 12. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Goto
Organization	Medical corporation Seiryukai group the Goto Clinic
Division name	Director
Zip code	493-0005
Address	170 Kisogawa-cho Satokomakinokata, Ichinomiya-shi, Aichi-ken, Japan
TEL	0586-87-7800
Email	info@oryza.co.jp

Public contact
Name of contact person	1st name Nozomi Middle name Last name Yamauchi
Organization	Oryza Oil & Fat Chemical Co. Ltd
Division name	Manufacturing Technology Department
Zip code	493-8001
Address	1 Kitagata-cho Numata, Ichinomiya-shi, Aichi-ken, Japan
TEL	0586-86-5141
Homepage URL
Email	seigi@oryza.co.jp

Sponsor
Institute	Oryza Oil & Fat Chemical Co. Ltd
Institute
Department

Funding Source
Organization	Oryza Oil & Fat Chemical Co. Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	IRB@takara-clinic.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	オリザ油化株式会社 (愛知県)

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 10 Month 13 Day
Date of IRB	2021 Year 10 Month 13 Day
Anticipated trial start date	2021 Year 11 Month 01 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 11 Month 02 Day
Last modified on	2022 Year 03 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052454